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Completed

NCT Number: NCT05949060

Effects of Self-Compassion Practice on Stress Reactivity Among Sexual Minority Women

This project will test the ability of brief self-compassion training to attenuate physiological and subjective responses to induced stress among sexual minority women, transgender people, and nonbinary people.

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Key information

Conditions

Stress Reaction Behavior Compassion Fractures, Bone Fractures, Stress Sexual Behavior Sexuality Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Syracuse University

Syracuse, New York, 13244, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be 18 years of age or older
  • Be fluent in English (i.e., speak and read English)
  • Have Internet access
  • Have a working email address
  • Self-identify sexual identity as LGBQ+ or another non-heterosexual identity AND gender identity as cisgender woman, transgender, nonbinary, or other gender minority identity
  • Currently live in Central NY

Exclusion criteria

  • Failing an inclusion criterion
  • Report having been hospitalized at an inpatient facility for psychiatric support within the past 6 months
  • Report being currently pregnant
  • Report a history of heart attack, unstable angina pectoris, heart failure, coronary heart disease, vascular, heart problems, stroke, or brain hemorrhage
  • Report being on blood pressure medication
  • Have resting systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 100 mmHg

Treatment and study plan

Compassion Intervention

Behavioral

The compassion intervention is a single-session 40-min intervention in which the participants practiced soothing rhythm breathing (i.e., they are directed to slow their breathing using a five-count inhale and five-count exhale). They will then be provided didactic instruction on compassion, and will then be guided through an experiential compassion practice adapted that encompasses cultivating feelings of compassion for a loved one and then for oneself.

Primary outcomes

  1. Change in Blood Pressure

    Time frame: Baseline, Immediate Follow-Up (40 minutes after Baseline), During TSST (45-50 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)

    Systolic and diastolic blood pressure will be measured with an Omron ocillometric blood pressure monitoring device before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.

  2. Change in Salivary Cortisol

    Time frame: Baseline, Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)

    Salivary cortisol levels will be collected using Salimetrics saliva swabs before the intervention and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.

  3. Change in Heart Rate Variability

    Time frame: Baseline, Immediate Follow-Up (40 minutes after Baseline), During TSST (45-50 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)

    Heart rate variability will be measured with BIOPAC MP160 System before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.

  4. Change in Heart Rate

    Time frame: Baseline, Immediate Follow-Up (40 minutes after Baseline), During TSST (45-50 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)

    Heart rate will be measured with BIOPAC MP160 System before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.

  5. Change in Skin Conductance

    Time frame: Baseline, Immediate Follow-Up (40 minutes after Baseline), During TSST (45-50 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)

    Skin conductance reactivity will be measured with the BIOPAC MP160 System before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.

  6. Change in Subjective Stress

    Time frame: Baseline, Immediate Follow-Up (40 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)

    Subjective stress reactivity will be measured with the six item State-Trait Anxiety Inventory (Marteau & Bekker, 1993), the Positive and Negative Affect Schedule (PANAS), and three visual analog scales before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.

Secondary outcomes

  1. Change in PTSD Symptoms

    Time frame: Baseline, Follow-Up (1-month)

    PTSD symptoms will be measured using the Posttraumatic Diagnostic Scale for DSM-5 (PDS-5; Foa et al., 2015). Possible scores on the PDS-5 range from 0 to 80. Higher scores indicate more PTSD symptoms.

  2. Change in Substance Use

    Time frame: Baseline, Follow-Up (1-month)

    Past 30-day substance use, including number of days of any alcohol use, hazardous drinking, cannabis use, prescription drug use, cigarette use, and other drug use was measured using questions from the 2020 National Survey on Drug Use and Health.

  3. Change in Dissociation

    Time frame: Baseline, Immediate Follow-Up (40 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)

    Change in dissociation will be measured with the five items adapted from scales which measure state dissociation in experience sampling studies (Mason et al., 2017; Vine et al., 2020). Dissociation will be measured before and after the intervention and before and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt. Possible scores for this measure range from 0 to 15. Higher scores indicate more dissociation.

  4. Change in Craving

    Time frame: Baseline, Immediate Follow-Up (40 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)

    Change in craving be measured with the 12-item Alcohol Craving Questionnaire - short form - revised (Singleton et al., 1994). Craving will be measured before and after the intervention and before and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt. Possible scores on this measure range from 12 to 84. Higher scores indicate more alcohol craving.

Sponsors and collaborators

Lead sponsor

Syracuse University

Other

Collaborators

  • GLMA: Health Professionals Advancing LGBTQ+ Equality

Registry information

Official study title

Dating and Sexual Violence Among Sexual Minority Women Living in Central New York (Project DAWN), Study B: Pilot RCT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2023
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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